FDA applicant
Peca Labs
FDA records 5 decisions for Peca Labs (Pittsburgh, PA) from 2018 to 2024: 5 510(k) clearances. All are in product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Peca Labs, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Peca Labs’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Peca Labs’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report